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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024907
Receipt No. R000027068
Scientific Title Effects of exercise training in peritoneal dialysis patients
Date of disclosure of the study information 2016/11/21
Last modified on 2018/07/20

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Basic information
Public title Effects of exercise training in peritoneal dialysis patients
Acronym Exercise training in peritoneal dialysis patients
Scientific Title Effects of exercise training in peritoneal dialysis patients
Scientific Title:Acronym Exercise training in peritoneal dialysis patients
Region
Japan

Condition
Condition Peritoneal dialysis patients
Classification by specialty
Endocrinology and Metabolism Nephrology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effects of 12-week home-based exercise training in peritoneal dialysis patients. Primary endpoint includes aerobic capacity and quality of life, and secondary endpoint includes parameters such as muscle strength, residual renal function, cholesterol, arterial stiffness.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Exercise capacity assessed by shuttle walking test and quality of life, evaluated 12 weeks after assignment
Key secondary outcomes Parameters including muscle strength,residual renal function, cholesterol, arterial stiffness, evaluated 12 weeks after assignment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Twelve-week home-based exercise training, including 20-30 minutes of aerobic exercise thrice-weekly and resistance training twice-weekly. Exercise intensity is determined by the result of shuttle walking test and major muscle testing at baseline. Aerobic exercise and resistance training are performed with the target of 40-60% of the peak oxygen uptake (VO2peak) and 70% of 1 repetition maximum (RM), respectively.
Interventions/Control_2 No treatment
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 1) Peritoneal dialysis outpatients.
2) Patients from whom written informed consent was obtained.
Key exclusion criteria 1) Patients who are contraindicated for exercise training. Concrete criteria are as follows: patients with uncontrolled persistent hypertension (systolic blood pressure >= 180 mmHg or diastolic pressure >= 110 mmHg); severe anemia (Hb < 7 g/dL); active proliferative diabetic retinopathy; prior symptomatic coronary artery or cerebrovascular diseases within the previous 3 months; uncontrolled heart failure (NYHA >= III); symptomatic or lethal arrhythmia; severe valvular diseases; and walking difficulty due to orthopedic, cerebrovascular and peripheral artery diseases.

2) Unstable PD patients. Concrete criteria are as follows: patients who undergo PD less than 3 months and those with uncontrolled uremia (BUN > 100 mg/dL, K > 6.0 mEq/L and HCO3 < 18 mmoL/L).

3) Patients deemed inadequate for monitoring during study period, as determined by investigators.
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shu Wakino
Organization Department of internal medicine, Keio University, School of Medicine
Division name Division of Endocrinology, Metabolism and Nephrology
Zip code
Address 35-banchi, Shinano-machi ,Shinjuku-ku,Tokyo, Japan
TEL +81-3-3353-1211(-0535)
Email shuwakino@z8.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiyotaka Uchiyama
Organization Department of internal medicine, Keio University, School of Medicine
Division name Division of Endocrinology, Metabolism and Nephrology
Zip code
Address 35-banchi, Shinano-machi ,Shinjuku-ku,Tokyo, Japan
TEL +81-3-3353-1211(-0588)
Homepage URL
Email kiyo.0817.piyo@keio.jp

Sponsor
Institute Division of Endocrinology, Metabolism and Nephrology Department of Internal Medicine Keio University, School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 21 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 11 Month 18 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 19 Day
Last modified on
2018 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027068

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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